Accessing Services

Application Process
The services of the PCIR are available once the PCIR application package has been submitted by an investigator and approved for implementation by the PCIR Protocol Review Committee.  The PCIR application package consists of the following documents:
--PCIR Application (5 pages)
--Human Subjects Protocol (approval may be pending - send stamped approval form when available)
--Consent Form(s) (approval may be pending - send stamped consent form(s) when available)
--Protocol (Grant application, sponsor protocol, study group protocol)
--Appendix I, the Data Safety Monitoring Process, IF your study involves more than minimal risk to the participant and you do not have a Data Safety and Monitoring Board (DSMB) in place

The PCIR Protocol Review Committee consists of the leadership of the PCIR, the Research Subject Advocate, and the Research Pharmacist and meets to review new applications on the 2nd Friday of each month.  Each member has reviewed the applications ahead of time and may make individual contact with the investigator if questions or concerns arise during his/her review.  The committee determines the specific service awards to be made.

The PCIR application, along with accompanying documentation, should be sent electronically to Beth Parrish (bmorton@uab.edu).  Additionally, two paper copies of each document should be sent to Beth Parrish, J1502, zip 6906.  This must be received in full by 12 noon on the first day of the month in order to be reviewed that same month.

For industry-sponsored studies, there is a $1500 fee for application and setup, due pending study approval.

For specific questions regarding the application process, please contact:
Beth Parrish, BS
Data and Protocol Manager
bmorton@uab.edu or 975-6115.

Approval Process
Within a couple of days of the application review, a formal letter is sent to the investigator advising him/her of the committee’s decision.  The letter spells out the specifics of the services awarded, the length of the award period, and the requirements of the investigator to initialize the study in the PCIR.  This letter must be signed by the PI and returned to the PCIR before the study can begin. 

After PCIR approval of a new study, the investigator must provide the following in order for the study to become active within the PCIR system:
--His/her signature on the returned, signed letter of award
--Provision of the study’s Oracle string (account number) to be used for billing
--Completion of an inservice (link to Study Implementation) to educate PCIR staff about protocol procedures to be carried out on the PCIR unit
--A payment of $1500 for application and setup fee for industry-sponsored studies
--Copies of the final approved IRB documents if approval was pending at the time of application

Industry rates